510(k) · Cleared
ClearedWichita Fusion Nail Fully Threaded Self-Tapping Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 19, 1999 after a 25-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 19, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993603 Wichita Fusion Nail Fully Threaded Self-Tapping ScrewHowmedica Osteonics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK042409 Modular Arthrodesis NailBiomet, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042409Modular Arthrodesis NailBiomet, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993603 | Wichita Fusion Nail Fully Threaded Self-Tapping Screw | Howmedica Osteonics Corp. | 1999 | — |
| +1 | K042409 | Modular Arthrodesis Nail | Biomet, Inc. | 2004 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Wichita™ Partially Threaded Self-Tapping Screw Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042409 | Modular Arthrodesis Nail | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042409 (Biomet, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
This device is intended for use with the Wichita™ Fusion Nail in cases for intramedullary knee arthrodesis. Arthrodesis is performed to relieve pain and to stabilize a knee joint that has been severely damaged as a result of trauma, infection, or failed previous surgeries (including previous total joint replacement). More specific indications include treatment of the sequelae of septic arthritis in patients who are not candidates for total knee…
Read the full statement (123 words)
This device is intended for use with the Wichita™ Fusion Nail in cases for intramedullary knee arthrodesis. Arthrodesis is performed to relieve pain and to stabilize a knee joint that has been severely damaged as a result of trauma, infection, or failed previous surgeries (including previous total joint replacement). More specific indications include treatment of the sequelae of septic arthritis in patients who are not candidates for total knee arthroplasty, irretrievably failed total knee arthroplasty (either septic or aseptic), Charot arthropathy, painful degenerative knee in patients who are not candidates for total knee arthroplasty, arthrodesis of the knee for salvage in tumor surgery, delayed or non-union after previous arthrodesis of the knee, and any other condition where arthrodesis is the treatment of choice.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993603: Wichita Fusion Nail Fully Threaded Self-Tapping Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026